The Brilinta Resubmission Journey: From FDA CRL to Approval
Hello Regulatory Scientists, Today, let’s delve into the journey of Brilinta (ticagrelor) from receiving an FDA Complete Response Letter (CRL) to achieving approval. Understanding this case provides valuable insights and lessons that can guide companies developing new drugs today. Regulatory History and Initial Submission Drug: Brilinta (ticagrelor) Mechanism of Action: P2Y12 receptor antagonist, which inhibits […]
What to Do After Your First CRL from the FDA: A Story of Turning Setbacks into Success
Introduction Imagine you’re a regulatory scientist at a pharmaceutical company. Your team has worked tirelessly for years, conducting clinical trials, collecting data, and finally submitting your New Drug Application (NDA) to the FDA. The anticipation builds as you await their decision, only to receive a Complete Response Letter (CRL). It feels like a punch to […]
CAR-T Cell Therapy in the FDA Spotlight
CAR-T Cell Therapy in the FDA Spotlight. FDA mandated boxed warnings for CAR-T cell therapies, this followed a 28 November 2023 communication that FDA was “Investigating Serious Risk of T-cell Malignancy Following BCMA-Directed or CD19-Directed Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies,” and a July — September 2023 Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event […]
Unleashing the Power of Cell Therapy
Introduction: In the realm of medical advancements, cell therapy stands as a beacon of hope, offering a revolutionary approach to healing that transcends traditional treatment methods. This groundbreaking field harnesses the body’s own cellular power to combat diseases and promote regeneration. Join us on a journey through the wonders of cell therapy and discover how […]